Challenges with real-world evidence to support HTA

Tarang Sharma of Novo Nordisk shares her thoughts on the challenges associated with using real-world evidence in HTA decision making.

The emerging need for real-world evidence in HTA decision making is becoming apparent as regulators seek reassurance that their decisions are relevant in the real world.

pharmaphorum interviewed expert in health economics and HTA, Tarang Sharma on this evolving environment and the associated challenges and how she sees this space evolving.

Tarang has worked within the field of Health Economics and Outcomes Research for the last decade. She recently joined Novo Nordisk’s Health Economics and HTA team to help develop appropriate patient access strategies and undertake studies to support HTA submissions for pipeline products.

Interview summary

RA: What changes would you say have been most noteworthy in the HTA space throughout your career?

TS: The one significant change is the economic crisis in the last four years or so, it has shifted the global focus to health economics and decision making.

Governments are now more interested in determining what’s cost effective, and ensuring that they are providing value.

And from the pharmaceutical perspective, this is no longer ‘nice-to-have’ information, it’s becoming a key requirement by most regulatory agencies.

In addition, the form of evidence has changed. For the last 20–30 years the focus has been very much evidence-based decision making. This is changing to a more evidence-informed approach where people are realising that it’s not going to be randomised controlled trials that lead to all the decisions. Actually different types of experts, patient views, all contribute to the decision-making process.

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“Governments are now more interested in determining what’s cost effective, and ensuring that they are providing value.”

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RA: What are the challenges associated with using real-world evidence to support HTA and market access?

TS: One of the main issues is quality of data. People are realising that if you are trying to understand what’s effective in clinical practice you need to know what works in the real world, and its importance is now being understood quite well. There are lots of registries and observational studies available, but not always at a sufficient methodological level or quality.

That’s really the area that needs further work so that it can be used more often going forwards.

RA: Why is real-world evidence so important to HTA?

TS: When you get to the stage of HTA you want to see what actually works in practice.

We need to make data so that it’s sensible and usable in the real world. If the evidence is easy to use in that sense – because that’s how it’s been collected in the first place – it can be adopted quite quickly, which has to be upside for both pharma as well as HTA agencies.

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“Ultimately people want to make decisions in a sensible and more pragmatic way now. “

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RA: Looking ahead what do you think that the HTA space will look in 10 years’ time?

TS: The first thing we will see is that it’s going to be more widespread.

Within the field of HTA I think there is focus now to see where we need to do more work.

Ultimately people want to make decisions in a sensible and more pragmatic way now.

The other thing is service delivery will become more honest, because the mechanisms of care need to be analysed as well as just individual aspects.

RA: Great, thank you very much for your time today and for your insights.

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About the interviewee:

Tarang has been working in the field of Health Economics and Outcomes Research for the last decade and joined Novo Nordisk’s Health Economics and HTA team at their global headquarters in 2012 to help develop appropriate patient access strategies and undertake studies to support HTA submissions for pipeline products.

Previously she was the Senior Analyst within the Research and Development team at NICE, managing a team of analysts to develop the methods and processes for the Institute, and an external lecturer at the Manchester Business School, University of Manchester for the MSc in healthcare management. Prior to that she was a Technical Analyst with the Centre for Clinical Practice at NICE, responsible for producing clinical guidance in-house for key prioritised clinical guideline topics. She has also worked for the Health Economics and Decision Science unit at the University of Sheffield developing HTAs for NICE, at the World Health Organisation Regional office for Europe in Denmark for country health systems, Ranbaxy Laboratories Ltd in India for pre-clinical trial studies and the Sackler Institute for Comparative Genomics for the US government in New York for molecular systematics amongst other roles.

She has a Master’s of Public Health (MPH) degree in health economics from University of Sheffield (UK), a MPH in quantitative assessment from University of Copenhagen (Denmark) and a Master’s of Science degree in Applied Recombinant DNA Technology from New York University (USA). She has authored several peer-reviewed articles, contributed to national and international guidelines and presented at various international conferences.